Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document titled "Select Updates for the Medical Device User Fee Small Business Qualification and Certification" for industry and FDA staff. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on February 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for small businesses on qualifying and certifying for medical device user fees. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 17, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies From European Commission 🇪🇺 A guide for manufacturers and notified bodies on the qualification and classification of Annex XVI products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on December 14, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Application for Certificates for free sale for devices qualifying under Regulation 2023-607 From Health Products Regulatory Authority (HPRA) 🇮🇪 A form for applying for Certificates for free sale for devices meeting Regulation 2023-607 qualifications. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 9, 2023 Other (Public Domain) 0 reuses 0 favorites
Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document on qualifying medical device development tools for industry, tool developers, and FDA staff. Topics include administrative and premarket procedures. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Reply from the Comprehensive Department of the State Drug Administration on whether automobile sales enterprises operating ambulances containing medical device products should apply for business qualifications From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2022-205 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 2, 2022 Other (Public Domain) 0 reuses 0 favorites
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for IRBs, clinical investigators, and sponsors on IRB responsibilities and GCP in reviewing qualifications and research sites. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 22, 2021 Other (Public Domain) 0 reuses 0 favorites
Provision No. 7802/2021 From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷 Article 8 of ANMAT Provision No. 6052/13 is hereby amended to read as follows: "The qualification shall be granted for a term of 5 (five) years after which it shall automatically expire, and the company shall not continue performing the activities for which it was duly qualified by this National… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 1, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission 🇪🇺 This document discusses the qualification and classification of software under EU regulations, with a focus on new technologies. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Review of qualification for the authorisation of personnel (MDR) From European Commission 🇪🇺 Review of qualification for the authorisation of personnel (MDR). Topics: Notified bodies. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Review of qualification for the authorisation of personnel (IVDR) From European Commission 🇪🇺 Review of qualification for the authorisation of personnel (IVDR). Topics: Notified bodies. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Food and Drug Administration on the accreditation of Hebei Province Medical Devices and Pharmaceutical Packaging Materials Inspection Institute of medical device testing object testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10136 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration on the accreditation of Guangdong Provincial Institute for Quality Supervision and Inspection of Medical Devices (State Food and Drug Administration Guangzhou Center for Quality Supervision and Inspection of Medical Devices) medical device testing object testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10135 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Notice of the General Administration of Food and Drug Administration on the Accreditation of the National Population and Family Planning Commission Pharmaceutical Quality Monitoring Center for Medical Device Testing Objects Testing Qualifications From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10133 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration on the recognition of Yunnan Medical Device Inspection Institute of medical device testing object testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10121 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration on the recognition of the State Food and Drug Administration Hubei Medical Devices Quality Supervision and Inspection Center (Wuhan National Quality Supervision and Inspection Center for Medical Ultrasonic Instruments) medical device testing object testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10128 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration on the recognition of the People's Liberation Army General Logistics Department of Health Drug Instrument Inspection Institute of medical device testing object testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10126 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration on the recognition of the Guangxi Zhuang Autonomous Region Product Quality Supervision and Inspection Institute of medical device testing object testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10119 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration on the recognition of Shanghai Medical Device Testing Institute (State Food and Drug Administration Shanghai Medical Device Quality Supervision and Inspection Center) medical device testing object testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10124 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Food and Drug Administration on the recognition of medical devices and pharmaceutical packaging materials (containers) testing laboratory in Hunan Province, medical device testing object testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10122 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites